Monocentric Pilot Study of Effect of Perioperative Hemodynamic Optimization on the Immune Function Parameters of Peripheral Blood Monocytes After Cardiac Surgery
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- HLA-DR Expression on monocytes after surgery
Study Overview
Brief Summary
Cardiac surgery patients have a high risk to suffer from postoperative infections. Some studies have shown, that humoral and cellular factors are associated with perioperative immunodysfunction and can increase the risk of postoperative infections. Monocytes in the blood and, especially alveolar macrophages are important for an adequate host defence. In studies the investigators have shown that hemodynamic parameters have a significant influence on the probability to develop postoperative infections. The aim of the study is to investigate, whether cardiac surgery patients have an altered immune function after surgery that is predictive for the latter development of subsequent infections and whether they benefit from a goal-directed volume and hemodynamic therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •elective cardiac surgery patient undergoing cardiopulmonary bypass
- •signed informed consent
Exclusion Criteria
- •pregnant or breast feeding women
- •Age <18 years
- •pulmonary disease with an oxygenation index <300mmHg
- •liver disease (>Child B)
- •HIV-Infection
- •Therapy with corticosteroids
- •Condition after transplantation
- •preexisting infection before operation
Arms & Interventions
advanced hemodynamic monitoring
advanced hemodynamic monitoring with pulse contour analysis ( LiDCO rapid) and goal-directed therapy
Intervention: Pulse contour cardiac output device (Device)
standard monitoring
hemodynamic monitoring based on the standard operating procedures of our clinic
Outcomes
Primary Outcomes
HLA-DR Expression on monocytes after surgery
Time Frame: 24 hours
Secondary Outcomes
- ICU stay(24 hours)
Investigators
Michael Sander
Vice Chair
Charite University, Berlin, Germany